Four Studies Published in The Lancet Show roflumilast (Daxas(R)), a New Oral Approach...

Four Studies Published in The Lancet Show roflumilast (Daxas(R)), a New Oral
Approach to COPD, Improves Lung Function and Reduces Exacerbations
-- Once-a-day tablet Daxas(R) (roflumilast) is a first-in-class treatment
under development targeting inflammation, the underlying cause of chronic
obstructive pulmonary disease (COPD)

ZURICH, Aug. 27 /PRNewswire/ -- Nycomed and Forest Laboratories today
announced that results of four phase III trials have been published in the
prestigious peer-reviewed medical journal The Lancet showing that roflumilast,
a phosphodiesterase 4 (PDE4) inhibitor, improved lung function and reduced
exacerbations in patients with moderate to severe COPD.

COPD is an under-diagnosed progressive lung disease that may lead to death.
Worldwide, COPD kills four people every minute and the World Health
Organization (WHO) predicts that it will be the third leading cause of death
by 2030. WHO estimates that 80 million people have moderate to severe COPD.

Roflumilast, a once-a-day oral tablet, would be the first in an entirely new
class of treatment for COPD if it receives regulatory approval from the
authorities in Europe (EMEA) and the US (FDA). The phase III
placebo-controlled trials of roflumilast evaluated the treatment in two
12-month (Lancet 2009; 374: 685-694) and two six-month studies (Lancet 2009;
374: 695-703), involving 4,500 patients in ten countries. Details of the
results of the four studies will be published in The Lancet on August 29 (data
and information under embargo until Friday, August 28 at 00:01am GMT).

The two 12-month studies published in The Lancet demonstrated that roflumilast
produced a statistically significant and clinically relevant reduction in
exacerbations (lung attacks that need treatment with systemic steroids or lead
to hospitalisation), even for patients who were also taking long-acting
bronchodilators. The studies showed a reduction in moderate to severe
exacerbations by 17 percent per patient per year (rate of 1.14 events per year
with roflumilast vs. 1.37 per year with placebo, p<0.001). The reduction in
exacerbations was irrespective of concomitant treatment with long-acting
beta-2 agonists, a standard bronchodilator therapy.

When added to standard bronchodilator therapies in the two six-month studies,
a clear trend for the reduction of exacerbations was observed with
roflumilast, over and above what was achieved with these therapies alone.
There was also a statistically significant difference with roflumilast in
other prespecified endpoints, including median time to first exacerbation
(moderate to severe in the salmeterol study, and mild, moderate and severe in
the tiotropium study) and in the proportion of patients in both studies
experiencing a mild, moderate, or severe exacerbation.

Lung function, as measured by FEV(1) (how much volume can be exhaled in one
second), was the primary or co-primary endpoint in all four studies. Across
the studies, roflumilast demonstrated a statistically significant improvement
in pre-bronchodilator FEV(1), in the range of 48 to 80 mL (p<0.001).

Nausea, diarrhoea and weight loss were the most common adverse events recorded
in patients in the four trials, but they were generally mild to moderate in
intensity and generally occurred in the first weeks of treatment.

Professor Peter Calverley, Professor of Respiratory Medicine, University of
Liverpool, UK, and the lead author of the 12-month studies, said: "COPD can
devastate people's lives and exacerbations can be extremely frightening, so a
novel tablet like roflumilast is really exciting for those of us treating
patients. Roflumilast acts differently to bronchodilators as it acts on the
underlying condition, not primarily impacting on everyday symptoms. It acts
slowly and the effects, as we saw in our studies, are gradual and sustained."

"Roflumilast could be an important new treatment for COPD," added Professor
Fernando Martinez, University of Michigan, also a lead author of the 12-month
studies. "We clearly need new options for patients with COPD and the results
of these studies, published in The Lancet, confirm that roflumilast is
beneficial. It reduced exacerbations, or lung attacks, and significantly
improved lung function, in a patient population whose lung function is very
poor."

Professor Leonardo Fabbri, Professor of Respiratory Medicine, University of
Modena and Reggio Emilia, Italy, and lead author of the six-month studies,
said: "Roflumilast has a novel mode of action and has the potential to become
the first of a new class of drugs and potentially the only completely new
treatment option for COPD in the next several years. These eagerly awaited
results, published this week in The Lancet, show that in addition to
confirming the sustained statistically significant improvements in lung
function, roflumilast also showed a trend to reducing exacerbations when given
in addition to long acting inhaled bronchodilators. The results of the two
six-month trials examining the additive effect of roflumilast on top of
salmeterol or tiotropium support and extend the findings of the 12-month
trials, by showing a clinically relevant lung function improvement in patients
with impaired lung function on top of maximum bronchodilation."

"The lung function improvements on top of current bronchodilation clearly
indicates that roflumilast improves lung function over and above what can be
achieved with other COPD treatments alone. It also demonstrates that
roflumilast works in a different way to current treatments and supports
roflumilast's potential to change how COPD is managed," added Professor Klaus
Rabe, Professor of Medicine at Leiden University Medical Center, also a lead
author of the six-month studies.

Nycomed's Executive Vice President R&D, Anders Ullman, said: "We are very
pleased with the results published in The Lancet this week. In four studies,
two 12-month studies and two six-month studies, roflumilast showed clear
therapeutic potential, decreasing exacerbations and improving lung function.
The uniformity of the results is really encouraging and gives us great hope
that our faith in roflumilast has been confirmed. We are now undergoing the
regulatory review process with the European and US authorities."

"Based on the results from the pivotal studies published this week, it appears
that roflumilast provides added activity on top of other commonly used
treatments for COPD," said Lawrence S. Olanoff, President and Chief Operating
Officer of Forest Laboratories. "Roflumilast represents the first in a new
class of agents to treat COPD and, if approved, would be the first oral
anti-inflammatory maintenance treatment for the disease."

About Roflumilast (Daxas(R))
Roflumilast( )is an orally administered phosphodiesterase 4 (PDE4) enzyme
inhibitor targeting cells and mediators in the body believed to be important
in the COPD disease process. Roflumilast is expected to act on the underlying
mechanism of COPD and related inflammatory diseases. If approved, roflumilast,
a once-a-day oral tablet, will be the first in an entirely new class of
treatment for COPD. It will also be the first oral anti-inflammatory treatment
for COPD patients. Current treatment for COPD patients includes the use of
inhaled bronchodilators and inhaled corticosteroids.

About COPD
COPD is an under-diagnosed progressive lung disease that may lead to death.
Worldwide, COPD kills four people every minute and the World Health
Organization (WHO) predicts that it will be the third leading cause of death
by 2030. WHO estimates that 80 million people have moderate to severe COPD.

Symptoms of COPD include breathlessness, chronic cough and excessive
production of phlegm. A significant worsening of symptoms called an
exacerbation or lung attack can last several weeks. Breathing becomes severely
compromised and patients may need to be admitted to a hospital. Exacerbations
are frightening events resulting in increased patient anxiety, worsening
health status, lung function decline and increased risk of death.

Smoking is a major contributory factor in western countries, and pollution
from fires for cooking and heating is an additional contributory factor in
less developed countries. Industrial and chemical pollutants can also cause
COPD.

Chronic inflammation in the lungs plays a significant role in COPD. Current
medications used to treat the condition deal mainly with symptoms rather than
the underlying disease. Roflumilast is a new PDE4 inhibitor being developed
specifically to target the chronic inflammation which is COPD-related.

About Nycomed
Nycomed is a privately owned global pharmaceutical company with a
differentiated portfolio focused on branded medicines in gastroenterology,
respiratory and inflammatory diseases, pain, osteoporosis and tissue
management. An extensive range of OTC products completes the portfolio.

Its R&D is structured around partnerships and in-licensing is a cornerstone of
the company's growth strategy.

Nycomed employs 12,000 associates worldwide, and its products are available in
more than 100 countries. It has strong platforms in Europe and in fast-growing
markets such as Russia/CIS and Latin America. While the US and Japan are
commercialised through best-in-class partners, Nycomed plans to further
strengthen its own position in key Asian markets.

Headquartered in Zurich, Switzerland, the company generated total sales of
euro 3.4 billion in 2008 and an adjusted EBITDA of euro 1.2 billion.

For more information visit www.nycomed.com

About Forest Laboratories
Forest Laboratories (NYSE: FRX) is a U.S.-based pharmaceutical company with a
long track record of building partnerships and developing and marketing
products that make a positive difference in people's lives. In addition to its
well-established franchises in therapeutic areas of the central nervous and
cardiovascular systems, Forest's current pipeline includes product candidates
in all stages of development and across a wide range of therapeutic areas. The
company is headquartered in New York, NY. To learn more about Forest
Laboratories, visit www.FRX.com.

Except for the historical information contained herein, this release contains
forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995. These statements involve a number of risks and
uncertainties, including the difficulty of predicting FDA approvals, the
acceptance and demand for new pharmaceutical products, the impact of
competitive products and pricing, the timely development and launch of new
products, and the risk factors listed from time to time in Forest
Laboratories' Annual Report on Form 10-K, Quarterly Report on Form 10-Q, and
any subsequent SEC filings.

For further information
Nycomed
Media:
General phone: +1 917 968 9795

Forest Laboratories, Inc.
Frank J. Murdolo, phone: +1 212 224 6714
Vice President - Investor Relations
Frank.Murdolo@frx.com

Notes to editors
Further details for the four trials will be presented at the European
Respiratory Society Annual Congress 2009, in Vienna, Austria, September 12 to
16, 2009.

12-Month Trials
The two replicate, 12-month trials were randomised, placebo controlled and
double blind. One 12 month study was conducted in 246 centres in 10 countries
and the second was conducted in 221 centres in eight countries.

COPD patients were over 40, and either former or current smokers with a
smoking history of at least 20 pack-years. The patients had symptoms of
chronic cough and sputum, their post-bronchodilator FEV(1) was less than or
equal to 50percent of the predicted value and they had at least one documented
moderate to severe exacerbation in the previous year. Approximately 50percent
of the patients were concomitantly using long acting beta agonists.

Patients were permitted to use short-acting bronchodilators to relieve their
symptoms as needed.

Compared with placebo, roflumilast significantly reduced the rate of
exacerbations and improved lung function in treated patients. The rate of
moderate to severe exacerbations in the study period (pooled data) was 1.14
per year in the patients treated with roflumilast compared with 1.37 per year,
in the placebo group. This represents an improvement of 17 percent (RR 0.83;
CI 0.75-0.92, p<0.001).

The pooled data for lung function using the pre-bronchodilator FEV(1)
measurement (forced expiratory volume in one second) showed an average
increase of 48mL (p<0.001) in roflumilast treated patients compared with the
placebo group. The improvement in post-bronchodilator FEV(1) was 55mL
(p<0.001) with roflumilast.

The differences found in exacerbation rates and lung function were similar
irrespective of whether roflumilast was used with or without a long-acting
beta-agonist.

Using another measurement, FVC (forced vital capacity, the lung capacity
measured when the patient is exhaling for as hard and as long as possible)
roflumilast patients also scored higher with an average increased FVC of 98 mL
(p<0.001) compared with the placebo group. These patients had not used a
bronchodilator prior to testing. The improvement in post-bronchodilator FVC
was 101 mL (p<0.001).

Roflumilast was well tolerated by most patients. Slightly more patients
discontinued the trial in the roflumilast group than those taking placebo (14
percent vs 11 percent). Diarrhoea, nausea and headache were the commonest
reasons for discontinuation. A reduction in weight, around 2kg, was seen
consistently across all the studies published in The Lancet. When patients
stopped taking roflumilast the majority regained weight. In addition, in the
12- month studies, only four patients out of 1,547 dropped out because of
weight loss.

Six-month trials
In the six-month trial patients used roflumilast or a placebo in conjunction
with commonly used long acting bronchodilators (inhalers).

In one trial, patients used salmeterol with roflumilast or placebo. In the
second trial, patients used tiotropium, a long-acting bronchodilator which
also reduces the production of mucus, with roflumilast or placebo. Patients
used "rescue medication" short-acting bronchodilators, as needed.

There were 933 patients in the salmeterol trial and 743 patients in the
tiotropium trial. Overall patients had moderate to severe COPD; were over 40,
current or former smokers with a history of smoking at least a pack a day for
10 years. In contrast to the 12-month trials, patients in the six-month trials
did not require a history of exacerbations. Patients recruited to the
tiotropium study were more symptomatic than those in the salmeterol study as
they were required to have daily chronic cough and sputum production and a
documented use of rescue medication.

Patients were seen and measured once a month for the first three months and
every six weeks for the last three months of the trial.

Compared with placebo, patients taking roflumilast in addition to salmeterol,
had an average increased pre-bronchodilator FEV(1) (forced expiratory volume
in one second) of 49mL (p<0.001).

Compared with placebo, patients taking roflumilast in addition to tiotropium
had an average increased pre-bronchodilator FEV(1) of 80mL (p<0.001).

There was a similar FEV(1) advantage in both trials when measurements were
taken after using a short-acting bronchodilator, an increase of 60mL (p<0.001)
in the salmeterol study and 81mL (p<0.001) in the tiotropium study.

Roflumilast was well tolerated by most patients. Slightly more patients
discontinued the trials in the roflumilast group than those taking placebo (13
percent vs 8 percent). Diarrhoea, nausea and headache were the most commonly
reported adverse events.

SOURCE Nycomed

Nycomed, Media: General phone: +1-917-968-9795; Frank J. Murdolo, Vice
President - Investor Relations, Forest Laboratories, Inc., +1-212-224-6714,
Frank.Murdolo@frx.com